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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Suspended |
Unique ID issued by UMIN | UMIN000032965 |
Receipt No. | R000037581 |
Scientific Title | Effects of medical equipments that improve physical functions on psychological states |
Date of disclosure of the study information | 2018/06/18 |
Last modified on | 2019/05/08 |
Basic information | ||
Public title | Effects of medical equipments that improve physical functions on psychological states | |
Acronym | Effects of medical equipments that improve physical functions on psychological states | |
Scientific Title | Effects of medical equipments that improve physical functions on psychological states | |
Scientific Title:Acronym | Effects of medical equipments that improve physical functions on psychological states | |
Region |
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Condition | |||||
Condition | Depressive symptoms | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | In recent years, it is becoming apparent that various organs and cells exchanges information dynamically through several neurotransmitters in the body and this phenomenon supports physical and mental health conditions. In this study, we attempt to reveal the effects of medical equipments that improve physical functions on psychological states such as flow experiences, empathy, and stress coping abilities. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | After 10-minute physical stimulation using a low frequency therapy device or a dry hot pack device, we ask the participants to conduct psychological tasks that can evaluate flow experiences / empathy / stress coping abilities and quantitatively evaluate the influence of transient physical stimulations on flow experiences / empathy / stress coping abilities . |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Placebo |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | Pseudo-randomization |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Perform a 10-minute physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment(program 1).
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Interventions/Control_2 | Perform a 10-minute physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment (program 2). | |
Interventions/Control_3 | Perform a 10-minute sham-physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment. | |
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Healty people | |||
Key exclusion criteria | Those who fall under the following which are thought to have a large electric influence compared with the intended effect are excluded. 1.people using psychotropic drugs and drugs that affect the mental state 2. people with sensory disorders such as dull warmth 3. pregnant women 4. people with malignant tumors and heart disease 5. people with skin irritation, injury or lesions 6. people who have a febrile disease, acute inflammation, and purulent disease 7. people who have a possibility of blood flow disorder 8. people who suffer from deep thrombophlebitis 9. people who judged that the doctor is inappropriate | |||
Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Aichi Medical University School of Medicine | ||||||
Division name | Department of Health and Psychosocial Medicine | ||||||
Zip code | 4801195 | ||||||
Address | 1-1 Yazakokarimata, Nagakute, Aichi | ||||||
TEL | 0561-62-3311 | ||||||
matsunag@aichi-med-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Aichi Medical University School of Medicine | ||||||
Division name | Department of Health and Psychosocial Medicine | ||||||
Zip code | 4801195 | ||||||
Address | 1-1 Yazakokarimata, Nagakute, Aichi | ||||||
TEL | 0561-62-3311 | ||||||
Homepage URL | |||||||
matsunag@aichi-med-u.ac.jp |
Sponsor | |
Institute | Aichi Medical University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Grants-in-Aid for Scientific Research <KAKENHI> |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Aichi Medical University |
Address | 1-1 Yazakokarimata, Nagakute, Aichi |
Tel | 0561623311 |
sec2030@mail.aichi-med-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 30 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Suspended | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037581 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |